This invention covers the field of application where users are needing protection from accidental punctures from scalpel blades during the use and storage of surgical scalpels. More importantly, this invention allows the user of the device to be either left or right handed while still being able to use the device with the controlling mechanism located next to the user's thumb. The user of this invention also is able to ascertain the position of the shield through tactile sensory perception as well as having the safety of knowing that removal of the blade is only accomplished by a secondary ejectment location of the shield which is not part of the normal operation of the shield.
Each year many users accidentally slice or puncture themselves with sharp instruments either during use, during transfer from one person to another or from inadvertent misplacement of sharps in potentially dangerous locations. This is especially dangerous in the medical arena, as potentially fatal diseases can be spread through accidental contact with sharps. Emergency Rooms are battlegrounds compared to the operating rooms where quick action amongst many people is required to save lives. Sharp protection is a must and must be easy to operate. Prior art is replete with many different styles of devices that act to cover sharp blades.
There are 4 main types of prior art that exist to prevent users from accidental contact with sharp blades. The 4 areas involve devices where 1) the sharp is retracted into the body of the device; 2) where the device is a disposable or single use application, where the entire sharp with the handle is not reused; 3) a device that moves in a non-linear fashion to cover the blade while it is not in use; and 4) those devices which remove a detachable blade from the handle of the device. Only the fourth type of devices is applicable to this invention as the shield slides in a linear path along the handle.
The fourth arena of the prior art involves the use of devices whereby the sharp is attached to and then removed from the handle. In one group, there are those devices where the sharp is directly attached to the handle and another group contains devices where the sharp is placed into a cartridge which is then placed upon the handle. Both groups involve handling of the sharp prior to its inclusion into some protective cover, increasing the chance of accidental puncture. In the first group, Herbert et al in U.S. Pat. No. 5,868,771 issued on Feb. 9, 1999, Newman et al in U.S. Pat. No. 6,626,925 issued on Sep. 30, 2003 and van der Westhuizen et al in U.S. Pat. No. 5,330,494 disclose the procedure of attaching the sharp to the handle and then attaching a sliding blade guard. Once the sharp is used, the blade can be removed along with the guard. Herbert uses existing style surgical handles, while van der Westhuizen and Newman use a unique handle that is modified at the distal end of the handle nearest the sharp, to receive the guard. Both devices require the user to load the sharps device onto the handle, requiring the unguarded sharp to be handled by those that the device is designed to protect, and often those people are wearing gloves which will reduce tactile feel. In a different approach disclosed by Noack in U.S. Pat. No. 5,312,429 issued on May 17, 1994, a unique blade with an opposed tang is removed by sliding the blade release element when the element is slid down the handle toward the sharp. This is a two handed operation involving two separate pieces. In the sliding of the element, if one's hand slips from the element it would be certainly cut by the exposed blade. Also the blade is without direction or restraint when released from its location on the handle. It could fly anywhere in the operating room as there is tension built up between the tang of the blade and the rest of the blade that was forced over the post on the handle.
Cartridge types highlighted by U.S. Pat. No. 7,207,999 to Griffin et al issued on Apr. 24, 2007, show the use of a cartridge that contains the blade for the scalpel. The cartridge doubles as a shield when it is retracted over the handle after the attachment of the blade to the tang of the handle. Each cartridge is unique to a particular style of blade and requires a two handed operation to remove and attach the blade. This extra cartridge material creates costly waste. It is also against current disposal regulations to mix plastics with metal sharps containers as they require different disposal techniques. U.S. Pat. No. 7,172,611 issued to Harding et al on Feb. 6, 2007 shows another cartridge but this one is required to use a special blade with “non-arcuate” holes which increase the cost and decreases its effectiveness to be used with a broad range of access. All cartridge style scalpels use the removal of the cartridge that contains the blade as the means for blade removal. Though safe, these devices are limited by needing unique cartridges to hold the wide variety of blades available.
Another adaptation of this concept, which is closer to the current invention, is found in the series of patents from Jolly et al, U.S. Pat. Nos. 5,827,309; 5,752,968 and 5,792,162 issued Oct. 27, 1998, May 19, 1998 and Aug. 11, 1998 respectively. These Jolly patents show a blade remover which first removes the tang of the blade from the post into a notch on the sliding guard. The '968 Patent discloses that “guard 30 can be advanced distally to force blade 50 from blade carrier”. The built in stresses mentioned above are now increased with a forcible removal of the blade with the sliding guard, increasing the chance for the blade to be misdirected about the operating room. In the second group, Gharibian in U.S. Pat. No. 5,527,329 issued on Jun. 18, 1996 and Cohn et al in U.S. Pat. No. 5,938,676 issued on Aug. 17, 1999 disclose the use of a cartridge system whereby the sharp is placed into a cartridge which is then encased by a guard prior to its placement onto the handle. This operation is safer as the sharp is guarded during assembly but creates a situation as each discloses a unique handle designed to receive the cartridges and shields. Cohn et al in U.S. Pat. No. 5,941,892 issued on Aug. 24, 1999 combines prior art by incorporating the cartridge concept that is “removably retained within the cavity” in the handle. This is a safe alternative but uses unique handles. All of the prior art in this section requires the use of two hands to safely operate the device which is at odds with current FDA compliance rules.
In the last arena of prior art, a guard is placed around a stationary blade. There is nothing unique about the concept, and its application can be seen from the simple to the complex. Applications of a more complex nature are found in Abidin et al in U.S. Pat. No. 5,662,669 issued on Sep. 2, 1997 and U.S. Pat. No. 5,569,281 issued on Oct. 29, 1996, Jolly et al in U.S. Pat. No. 5,741,289 issued on Apr. 21, 1998, Matwijcow in U.S. Pat. No. 5,207,696 and Dolgin et al in U.S. Pat. No. 5,071,426 issued on Dec. 10, 1991. Matwijcow discloses a rack and pinion system for movement of the guard over the blade which causes a reverse sequence of logic, as the user needs to pull back to move the guard forward. This could be confusing in the fast paced operating room where several different types of devices might be used at once. Dolgin also uses a “linkage system” to extend the blade guard “over a substantially greater distance than the distance which the surgeon's fingers move in operating the actuating mechanism”. This is an unnecessarily complex and expensive concept using unique handles which require manual loading of the blades onto the handle. Jolly provides for both linear actuation of the guard along with a rotational movement of the guard and blade away from the handle for cleaning purposes. This device is complex and expensive to manufacture and use. The Abidin '281 patent discloses a guard which “comprises an inverted U-shaped channel member telescopically mounted within the hollow handle for sliding movement therein”. It is held in position by an exposed pin which would be in the way of the surgeon's hands and could be accidentally triggered to move at the improper time. This device is also not usable with currently used scalpels and it requires a unique handle. Abidin '669 is another internally guided blade guard with a unique handle. But this patent also discloses in column 10 line 11, that it does not work with conventional scalpel blades. '669 does combine a blade guard and a blade ejector, but FIG. 36 details the need for two handed operation to remove the blade. FIG. 45 and FIG. 48 show that the blade is not restrained after it is removed from the handle, and as described above, there is a considerable amount of tension on the blade. The disclosure details the added tension as the guard actually pushes the blade off of the post upon which it is attached. There is nothing to restrain the loose blade. An unrestrained blade could fly off anywhere in the operating room and this is not a safe method of removal. '669 also discloses in FIG. 32 the complicated way of attaching the blade with two small pins, which would be very difficult with gloved hands in a hurried operating room. FIG. 130 of '669 shows the user sliding the guard forward using their forefinger, which would present an obvious problem should the guard become slippery due to bodily fluids, and the user's finger slips from the guard onto the exposed blade.
The inventor of this current invention has his own prior art in the field of scalpels that have a blade that is attached/detached from a handle, but differ substantially from the current invention. U.S. Pat. No. 8,156,653 issued on Apr. 17, 2012 to Austria, discloses a top rail mounted scalpel with three basic segments. That invention requires the use of two hands in order to eject the blade and the blade becomes trapped in the shield, requiring the use of another action by the user to get rid of the sharps blade, which is not desirable as well as having an impediment that all of the existing prior art possesses. The inability to be ambidextrous, allowing for left handed and right handed users to operate and to be trained upon one instrument in the same manner, while enjoying all of the advantages of the “right” handed version.
There is a need to preclude the problems associated with the prior art and the current state of technology in this field. It would be preferable to produce a device that would provide current users with a device that would improve upon some of the shortcomings of the prior art. Industry has set standards for their equipment and it would be desirable to have a device that fits their standard equipment, rather than adapt to new equipment. Sharps users, especially surgeons, are used to the weight, balance, fit, form and feel of their tools of the trade, and are reticent to change. It is well practiced in the medical field, that metal sharps handles are used because they possess a certain weight and balance that plastic handles have a hard time replicating. Industry needs to adapt protections to currently used sharps, as new devices are usually met with skepticism and doubt, and are thus not used. Industry does not want to carry duplicative inventories of many similar products because they do not work with one another.
It is also important to recognize that though only 7% of the population are considered left-handed, over 15% of all surgeons are left-handed according to the British Medical Journal in 2005, which found that left-handed surgeons are forced to use right handed devices causing a greater incident of accidental punctures from sharps. Left handed surgeons should be able to use devices designed for left-handed surgeons while accommodating the number of devices that a hospital must have in its inventory. A device that is capable of use by right or left handed surgeons reduces the amount of inventory that must be carried by the surgical institution.
It would be desirable to have a new device made in such a manner that it could have multiple users, and could be reusable. It would be desirable to have the device made of autoclavable plastic or metal and designed so that it will not have any hidden recesses or other cavities that would trap harmful bacteria precluding the chance that it could be autoclavable. It would be desirable and advantageous to possess a blade removing apparatus which is designed not to interfere with a user's single handed operation of the device while insuring that accidental removal of the blade is eliminated.
It would be desirable to have a scalpel to be able to easily remove and change blades during surgical procedures, whereby one handle is capable of receiving multiple sizes and shapes of blades.
These and other features, advantages, and objects of the present invention will be further understood and appreciated by those skilled in the art by reference to the following specification, claims, and appended drawings.